MAUDE Adverse Event Report: SOCLEAN INC. SOCLEAN 3; DISINFECTANT, MEDICAL DEVICES

Patient Problems Dyspnea (1816); Vertigo (2134); Dizziness (2194); Dysphasia (2195)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Constant lightheadedness and vertigo, as well as shortness of breath and ability to talk coherently.Many specialists have evaluated me, but everything appears fine or normal for my age (65).The suspected cause soclean 2 leaking ozone into the bedroom and remaining in the tube.I purchased a soclean 3 and installed it and used it 2 times and pulled it and returned it after reading about the ozone issues.I was told there is no test to determine if i have ozone in my body.I have seen many doctors and no one can tell me why i'm always dizzy.After researching soclean, i determined that the door and hose entry are not tight, therefore leaking ozone into the bedroom.My wife is having asthma attacks, which she never had before.I removed the soclean 2 weeks ago.My wife is noticing a change.I haven't.We purchased a $600 nuwave airpurifier and it has been running for at least 2 weeks, and still no change.I'm willing to see any specialist or take any medical test to determine what is wrong with me.Reference report mw5148541.

• Brand Name: SOCLEAN 3
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 18237090
• MDR Text Key: 329668725
• Report Number: MW5148542
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPRIN.; ATORVASTATIN 40MG.; B12.; LINSOPRIL 40MG.; METFORMIN.; NEXIUM 40MG.; TAMSULOSIN.; XYZAL.
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White